ADVANCE® KFTCNP4LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI M684KFTCNP4L1), received between Jun 22, 2020 and Aug 20, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Break; Break

  ALLEGEDLY, THE DISTAL PART OF THE FEMORAL COMPONENT DID BREAK OFF. ADDITIONAL, RESULTANT WEAR OCCURRED ON THE TIBIAL INSERT. THE SURGERY WAS EXTENDED MORE THAN 30 MINUTES.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 22850300 ↗
• InjuryJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR / ASEPTIC LOOSENING TIBIA. SRNJR NUMBER: 5123099. SIDE: L. GENDER: M.

  Patient problems: Unspecified Infection

  MAUDE report 19638870 ↗
• InjuryApr 17, 2023Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: 5057460. SIDE: L . PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Insufficient Information

  MAUDE report 16751067 ↗
• InjuryOct 19, 2022Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR/ASEPTIC LOOSENING TIBIA REVISION NJR NUMBER: (B)(4). SIDE: L . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Failure of Implant

  MAUDE report 15634959 ↗
• InjuryJun 29, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR. COMPONENT NOT REVISED: ADVANCE II COCR TIBIA BASE NONPOROUS SZ 4 STANDARD, PRODUCT ID: KTCCNP40, LOT ID: 1494920, REVISION NJR NUMBER: (B)(4). SIDE:L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10206797 ↗
• InjuryJun 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION. REVISION NJR NUMBER: (B)(4), SIDE: L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10194395 ↗
• InjuryJun 24, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY , MALALIGNMENT AND PAIN. REVISION NJR NUMBER: 4394823. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Pain

  MAUDE report 10192078 ↗
• InjuryJun 24, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR AND ASEPTIC LOOSENING TIBIA. REVISION NJR NUMBER: 4339248. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10188949 ↗
• InjuryJun 22, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY; MALALIGNMENT; STIFFNESS COMPONENT NOT REVISED: PATELLA REVISION NJR NUMBER: (B)(4); SIDE: L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Loss of Range of Motion

  MAUDE report 10179576 ↗